Chronic Cough, Dysphagia, Extraesophageal Reflux, Laryngopharyngeal Reflux
Conditions
Keywords
Extraesophageal reflux, Laryngopharyngeal reflux, Dysphagia, Chronic cough, high-resolution manometry, 24-hour pH-impedance monitoring
Brief summary
The aim of this project is to perform a detailed evaluation of upper esophageal sphincter function and the swallowing mechanism in patients with swallowing disorders or suspected extraesophageal reflux using high-resolution manometry with impedance and 24-hour pH-impedance monitoring.
Detailed description
The project seeks to improve diagnostic accuracy, identify functional abnormalities that are not detectable by conventional diagnostic methods, and establish a foundation for more effective and targeted therapeutic strategies. The upper esophageal sphincter (UES) represents a crucial functional structure at the junction of the digestive and respiratory tracts. Its proper function is essential for the coordination of the swallowing process and for the protection of the upper airways. Disorders of the UES may be associated with a wide range of otorhinolaryngological symptoms, including dysphagia, globus pharyngeus, chronic cough, hoarseness, laryngeal dysfunction, and voice disorders. Modern diagnostic techniques, such as 24-hour esophageal impedance monitoring and high-resolution manometry (HRM), enable detailed assessment of gastroesophageal reflux and esophageal pressure dynamics, thereby offering new possibilities for the diagnosis and understanding of these conditions.
Interventions
DIAGNOSTIC_TESTHigh resolution oesophageal manometry with impedance
Patients with extraoesophageal reflux and dysphagia will undergo high resolution oesophageal manometry with impedance.
DIAGNOSTIC_TEST24-hour pH metry
Patients with extraoesophageal reflux will undergo 24-hour pH-metry.
Sponsors
University Hospital Ostrava
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
No masking will be used in the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age 18-75 years * patients with swallowing difficulties suspected of having a functional oesophageal disorder or patients with clinical signs of extra-oesophageal reflux (Reflux Symptom Index \[RSI\] ≥ 13 or Reflux Symptom Score-12 \[RSS-12\] ≥ 11) signed informed consent
Exclusion criteria
* patients with a diagnosed tumor of the esophagus or upper airway, or with strong clinical suspicion of a tumor of the esophagus or upper airway * severe neurological disease affecting swallowing * pregnancy * surgery involving the head, neck, or esophagus within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAET (Proximal Acid Exposure Time) | 24 hours | PAET (Proximal Acid Exposure Time) - acid exposure to the proximal oesophageus will be measured in per cent of the whole 24-h period. |
| Upper esophageal sphincter (UES) Integrated Relaxation Pressure (IRP) | 15 minutes | UES IRP is a measure of the extent of UES relaxation measured in mmHg |
| UES Maximum Admittance | 15 minutes | UES MaxAd is the highest admittance value recorded during trans-sphincteric bolus flow measured in milliseconds. |
Countries
Czechia
Contacts
CONTACTJiří Hynčica
PRINCIPAL_INVESTIGATORDominik Tichý, MD
University Hospital Ostrava
Outcome results
None listed